Lower Limb SurgeryNCT00988234
Comparison of Two Position for Ultrasound Guided Lumbar Plexus and Sciatic Nerve Block
A study testing SGPP, SGTPP and SGLP in people with Lower Limb Surgery, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
In the present study, the investigators will test the effect of two position on posterior lumbar plexus and subgluteal or sub-greater trochanter sciatic nerve block. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lower Limb Surgery
- What is being tested?
- SGPP, SGTPP and SGLP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Apr 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 75 years old
- elective unilateral lower limb surgery
- ASA Physical Status ASA I-III
Who cannot join
- age <18 or >75 year old
- ASA Physical Status >ASA III
- abnormal blood coagulation
- infection near puncture place
- nerve injury
- bilateral lower limb surgery
Show all 9Show fewer
- patients with lumbar vertebral trauma
- inability to be properly positioned
- chronic narcotic therapy or illicit drug use
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Comparison of Lateral Decubitus Position Versus Prone Position for Ultrasound Guided Posterior Lumbar Plexus Block and Sciatic Nerve Block
In the present study, the investigators will test the effect of two position on posterior lumbar plexus and subgluteal or sub-greater trochanter sciatic nerve block.
Read the detailed description
The posterior lumbar plexus block approach was described approximately 30 years ago, using surface anatomical landmarks and a loss-of-resistance technique, but over the years it was almost abandoned for its low successful rate, the huge numbers of adverse effects and its difficulties to be performed. The introduction of the nerve stimulator and ultrasound guided technique in recent years increased the success rate in various peripheral nerve blocks and decreased adverse effects. Ultrasound guided LPB as well as sciatic nerve block technique in a small patient population resulting in a encouraging result, but published clinical data on optimal patient position for ultrasound-guided LPB are limited. We designed this prospective randomized study to compare the success rate, time of performance and complications of ultrasound guided posterior lumbar plexus block as well as subgluteal or sub-greater trochanter sciatic nerve block under lateral decubitus position v.s. prone position.
- Conditions
- Lower Limb Surgery
- Being tested
- SGPP, SGTPP, SGLP, SGTLP
- Keywords
- Lumbar plexus block, sciatic nerve block, position, ultrasound guidance, elective lower limb surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGPPProcedure or surgery
ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under prone position
SGTPPProcedure or surgery
ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under prone position
SGLPProcedure or surgery
ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under lateral decubitus position
SGTLPProcedure or surgery
ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under lateral decubitus position
| Study group | Role | What they receive |
|---|---|---|
| SGPP | Experimental | ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under prone position Receives: Procedure: SGPP |
| SGTPP | Experimental | ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under prone position Receives: Procedure: SGTPP |
| SGLP | Experimental | ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under lateral decubitus position Receives: Procedure: SGLP |
| SGTLP | Experimental | ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under lateral decubitus position Receives: Procedure: SGTLP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block success defined as loss of sensation to pinprick in each of the lumbar plexus and sciatic nerve distributions when measured 30 min after block performance.
Measured: 30min
Motor blockade was evaluated by assessing the strength of knee extension (femoral nerve), thigh adduction (obturator nerve), and plantar flexion and dorsiflexion of the ankle (sciatic nerve) 30 min after block performance.
Measured: 30min
Secondary outcomes (1)
block execution time, depth of the nerve, needle depth, duration of the sensory and motor blockade, complications such as inadvertent needle puncture of epidural space, dural puncture, peritoneal puncture, and kidney or ureter puncture and nerve injury.
Measured: within 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb SurgeryStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Investigators
- Yuke Tian, MD., Study chair, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988234
- Sponsor's protocol ID
- TJHMZK01001
- Status last verified
- Feb 2011
- First submitted
- 1 Oct 2009
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lateral Decubitus Position Versus Prone Position for Ultrasound Guided Posterior Lumbar Plexus Block and Sciatic Nerve Block
- ClinicalTrials.gov ID
- NCT00988234
- Acronym / sponsor ID
- TJHMZK01001
- Conditions
- Lower Limb Surgery
- Keywords
- Lumbar plexus block, sciatic nerve block, position, ultrasound guidance, elective lower limb surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the present study, the investigators will test the effect of two position on posterior lumbar plexus and subgluteal or sub-greater trochanter sciatic nerve block.
Detailed description
The posterior lumbar plexus block approach was described approximately 30 years ago, using surface anatomical landmarks and a loss-of-resistance technique, but over the years it was almost abandoned for its low successful rate, the huge numbers of adverse effects and its difficulties to be performed. The introduction of the nerve stimulator and ultrasound guided technique in recent years increased the success rate in various peripheral nerve blocks and decreased adverse effects. Ultrasound guided LPB as well as sciatic nerve block technique in a small patient population resulting in a encouraging result, but published clinical data on optimal patient position for ultrasound-guided LPB are limited. We designed this prospective randomized study to compare the success rate, time of performance and complications of ultrasound guided posterior lumbar plexus block as well as subgluteal or sub-greater trochanter sciatic nerve block under lateral decubitus position v.s. prone position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SGPP | Experimental | Procedure: SGPPultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under prone position |
| SGTPP | Experimental | Procedure: SGTPPultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under prone position |
| SGLP | Experimental | Procedure: SGLPultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under lateral decubitus position |
| SGTLP | Experimental | Procedure: SGTLPultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under lateral decubitus position |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 75 years old
- elective unilateral lower limb surgery
- ASA Physical Status ASA I-III
Key exclusion criteria (9 listed)
- age <18 or >75 year old
- ASA Physical Status >ASA III
- abnormal blood coagulation
- infection near puncture place
- nerve injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGPPultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under prone position | Procedure or surgery | SGPP |
| SGTPPultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under prone position | Procedure or surgery | SGTPP |
| SGLPultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under lateral decubitus position | Procedure or surgery | SGLP |
| SGTLPultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under lateral decubitus position | Procedure or surgery | SGTLP |
Primary outcome
Block success defined as loss of sensation to pinprick in each of the lumbar plexus and sciatic nerve distributions when measured 30 min after block performance.
Time frame: 30min
Motor blockade was evaluated by assessing the strength of knee extension (femoral nerve), thigh adduction (obturator nerve), and plantar flexion and dorsiflexion of the ankle (sciatic nerve) 30 min after block performance.
Time frame: 30min
1 secondary outcome
block execution time, depth of the nerve, needle depth, duration of the sensory and motor blockade, complications such as inadvertent needle puncture of epidural space, dural puncture, peritoneal puncture, and kidney or ureter puncture and nerve injury.
Time frame: within 48h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuke Tian, MD. study chair
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SGPP, SGTPP and SGLP in people with Lower Limb Surgery, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Block success defined as loss of sensation to pinprick in each of the lumbar plexus and sciatic nerve distributions when measured 30 min after block performance. (time frame: 30min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2011.